DK169711B1 - A dressing - Google Patents

Abstract

The skin plate product according to the invention is an adhesive, flat skin plate product for use as a semi-manufacture in the production of dressings, skin and wound care devices, fastening means for dressings, ostomy equipment, wound drains and catheters for incontinence equipment, in particular for men, and for use in electrodes for application to the skin, the said skin plate product having an area being delimited by the periphery of the product, and a first surface and a second surface consisting of two or more essentially non-mixed material units (1, 1', 2, 2', 2a, 2b, 2c, 4, 11, 12, 21, 21', 22, 22', 31, 32, 33, 41, 42, 43), at least two material units being of different material, of which at least one material unit is a skin friendly self-adhesive material, and where a first material unit (1, 1', 11, 21, 21', 31, 41) extends throughout the area of the entire product, this material unit further constituting at least a portion of the first surface (6, 26, 26', 36, 46) and the second surface (5, 25, 25', 35, 45), respectively, and the additional material unit or units constituting the other portion of the first and the second surface, respectively, and having a thickness which extends at least somewhat into the thickness of the product in a direction which intersects the first or second surface of the product.

Description

- i - DK 169711 B1

The present invention relates to an adhesive flat skin plate product for use as a semi-finished product in the manufacture of bandages, skin and wound care agents, dressing means, ostomy equipment, breast prostheses, ulcers and catheters, for incontinence equipment, especially for men, and for use in skin care. 5 electrodes, and a method of making such a skin plate product.

A wide variety of skin plate products of this kind are known which comprise or comprise a skin-friendly adhesive material which e.g. may consist of a continuous phase containing an adhesive and e.g. is made up of an elastomer, a plasticizer for the elastomer, an adhesive-promoting resin and optionally an oil-based extender as well as an antioxidant. Often there is a discontinuous phase consisting of one or more water-soluble or water-swellable hydrocolloids, starch derivatives or cellulose derivatives or hydrophilic polymers, and optionally one or more drugs.

20 In the applicant's DK Patent No. 157,899, a flat skin plate product of the type mentioned initially is described, which consists of alternating material units of at least two different species, at least one of which is a skin-friendly self-adhesive material. The material units are generally 25 parallel and extend all the way through the product in a direction that cuts the main surfaces of the product, preferably perpendicular. The material unit can e.g. be parallel or coaxial layers so that the product has the character of a laminate whose individual layers are quite short. They can also be 30 short strings.

This known skin pad product has the advantage that it can be brought, in addition to the adhesive material itself, to contain other components for special purposes, e.g. containing 35 antiseptics, drugs or other biologically active substances - 2 - DK 169711 B1 substances or liquid-conducting or electrically conductive structures.

The skin plate product known from DK patent 157,899 is prepared by coextruding the various material units or by rolling up on top of each other layers of the different material units to form a long cylindrical mass, which is then cut into thin slices.

10

In practice, it has proved to be very cumbersome and costly to produce the product, as the handling of the incoming adhesive mass and the cutting step places great demands on the machinery used and at the same time it is necessary that the cutting station be kept completely free of adhesive residues. As a result, it is often necessary to stop production to clean the cutting station. At the same time, there is a fairly large wastage percentage, with the thin adhesive slices easily curling together at the cutting edge.

20

All in all, these production difficulties contribute to costing the product considerably.

The skin plate product known from DK Patent No. 157,899 has the good feature that it is possible to vary the properties in the face direction, which gives a great degree of freedom in the design of the product. The various alternating material units may e.g. consist of materials having different adhesive properties, as well as one or more of the material units may be non-adhesive. Furthermore, the material units may have more or less pronounced barrier properties, be liquid conductive or electrically conductive to varying degrees, or contain wound healing substances, drugs or absorbent materials.

35 - 3 - DK 169711 B1

It is apparent from DK Patent No. 157,899 that the alternating layers of material can further form an angle with the surfaces of the skin plate product. However, such products are in practice very difficult to produce in a profitable manner.

5

Thus, the skin plate product known from DK Patent No. 157,899 has the less good property that both surfaces of the skin plate necessarily exhibit the same material configuration.

This is not always appropriate as the two surfaces must be adhered to different materials, (i) one to the skin, and (ii) the other to e.g. a back cover layer, an ostomy flange or other.

The object of the present invention is to provide a skin plate product of the kind specified in the preamble of claim 1 which has essentially the same good properties as the skin plate product patented in DK patent 157 157 and which is at the same time substantially cheaper to manufacture.

20

It is a further object of the present invention to provide a skin plate product of the kind set forth in the preamble of claim 1 which has substantially the same good properties as the skin plate product patented in DK Patent No. 157,899 and wherein the two surfaces of the skin plate product may be different from each other.

This is achieved according to the invention by the characterizing part of claim 1.

30

Thus, the skin plate product may consist of two or more different materials, with at least one material being a skin-friendly adhesive.

The skin-friendly adhesive may be of any kind, e.g. an acrylic adhesive, a hydrogel adhesive or a hydrocolloid adhesive. The adhesive material can e.g. include rubber, rubber-like synthetic homo, co or block copolymers, polyacrylate and copolymers thereof, polyurethane, silicone, polyisobutylene, polyvinyl ether, and natural or synthetic resins or mixtures thereof optionally containing ZnC 2. thickeners and others, and optionally hydrocolloids and / or various drugs such as antiseptics, hormones, nicotine and more.

Of suitable skin-friendly adhesives, e.g. mentioned are those mentioned in GB patent specification 1 280 631, in DK patents 127 578, 148 408, 154 806, 147 226 and 154 747, 15 in EP Publication Nos. 97 846 and 415 183, in SE Publication no. 365 410, in WO Publication No. 88/6894, in U.S. Patent Nos. 339,546, 4,093,673, and 4,867,748, and in NO Publication No. 157,686.

20

A further example of a useful adhesive material is that known from Applicant DK Patent Nos. 147,034 and 147,035 (corresponding to U.S. Patent Nos. 4,231,369 and 4,367,632). The adhesive materials referred to herein comprise (I) a continuous phase containing (a) a physically crosslinked elastomer in the form of one or more styrene-isoprene-styrene block copolymers or ethylene-propylene block copolymers, (b) a hydrocarbon resin in the form of a polymer or copolymer of cyclopentadiene, dicyclopentadiene, α-pinene and / or O-pinene, 35 - 5 - (c) an antioxidant, (d) optionally an oil extender consisting of one or more mineral oils, and (e) optionally a plasticizer which is polar to the elastomer, e.g. an ester of a polyethylene glycol or polypropylene glycol, or an ester of a dihydric polybasic carboxylic acid having a preferably aliphatic alcohol, and (II) a phase dispersed phase consisting of one or more water-swellable hydrocolloids.

15

A particularly preferred adhesive is that described in U.S. Patent No. 3,339,546, including in particular a adhesive comprising polyisobutylene and one or more aqueous liquid swellable hydrocolloids.

20

Further, one or more of the devices, if they do not want to come into contact with the skin during use, may consist of a non-skin-friendly adhesive material.

According to the invention, at least one of the material units can consist of a material which inhibits or prevents the migration of substances to and from the contact units with these material units, self-adhesive or non-adhesive material units. In other words, these are more or 30 less efficient barrier-forming material units. These barrier creating material units can be of several different species, viz. they may have different barrier effects for substances of the same kind or have barrier effects for different substances.

35 - 6 - DK 169711 B1

The embodiment is particularly important in cases where the units of the self-adhesive adhesive are in contact with units of another kind and it is desirable to prevent substance migration into or out of these units of another kind.

At least one of the species of the material units may consist of a material which inhibits or prevents the migration of aqueous liquids to adjacent hydrocolloid containing self-adhesive materials.

10 By a substance-retardant material is meant a material where, for example, fluid travels more slowly than in a neighboring material.

According to the invention, the anti-doping or anti-doping units may be in whole or in part of plastic or metal film or foil. Such barrier films or films will most often be perforated or in the form of mesh and have a thickness of 10-100 µm and e.g. consist of polyolefins, polyester, polyvinyl chloride, aluminum or 20 laminates thereof. However, such a barrier film or film will most often be placed in contact with another other unit for production reasons, these units together being preferably thicker than 0.1 mm.

The fabric migration inhibitory or inhibitory material units may furthermore, according to the invention, consist of a material which is extensible under the influence of low forces and is also more or less hydrophobic, and contains an adhesive elastomer mass and hydrocolloid, optionally in another amount or another species than in the adjacent material unit (s).

From DK Patent No. 157,899, it is known to select the alternating layers such that at least one layer is of a fluid-migration or inhibitory material. In the skin plate product described therein with fluid retardant or - preventive layers, when used in an ostomy device or bandage for exuding wounds, a somewhat extended life of the skin-facing adhesive surface is obtained, with the substance retardant or 5 obstructing layers inhibit the migration of fluid in the skin direction of the skin pads product.

The skin plate product according to the invention can also be manufactured to inhibit the movement of fluid in the skin direction of the skin plate product.

In particular, a skin plate product consisting of a first material unit of a skin-friendly adhesive having a relatively high cohesion and containing hydrocolloid is preferred, and a 15 or more other material units, at least one of which is of a skin-friendly adhesive having a relatively low cohesion, and which also contains hydrocolloid. .

Thus, it has been found that the rate of fluid migration in a hydrocolloid-containing adhesive is dependent on the cohesion of the adhesive, i.e. the lower the cohesion, the faster the fluid migration, and vice versa.

The rate of fluid migration is also dependent on the amount of 25 and the nature of hydrocolloid present in the skin plate product, such that the rate of fluid migration increases with increasing content and increasing absorbent capacity of the hydrocolloid.

30 However, it is very important that the total liquid absorbing capacity of the skin plate product is high, since the life of the skin plate product is highly dependent on this capacity.

Of particular adhesives for this preferred skin plate product 35, in particular, are the adhesives disclosed in US Patent No. 3,339,546 and in particular adhesives containing a binder consisting of polyisobutylene and optionally a rubber, especially butyl rubber, as well as hydrocolloid. , optionally in the form of a mixture of various hydrocolloid materials such as gelatin, pectin, guar and Na-carboxymethylcellulose.

5 Adhesives of this kind may constitute both the more cohesive first material unit and one or more less cohesive other material units.

The cohesion of such adhesives can be varied by changing the molecular weight of polyisobutylene or by adding or increasing the content of an additional binder in the form of a second higher molecular weight elastomer.

In a particularly preferred embodiment, the first material unit consists of a cohesive adhesive composed of low molecular weight polyisobutylene such as that sold by EXXON under the trade name "Vistanex LM-MH" (average molecular weight Mw = 82,000 g / mol), butyl rubber such as that sold by EXXON under the trade name "Butyl 007" (Mw = 420,000 20 g / mol), and hydrocolloid, e.g. in the form of a substantially equal mixture of gelatin, pectin and Na-carboxymethyl cellulose. The total hydrocolloid content is preferably between 30 and 70% and most preferably about 30%. 50%. Further, one or more of the other units consists of a less cohesive adhesive composed of low molecular weight polyisobutylene, e.g. "Vistanex LM-MH" and between 30 and 70% hydrocolloid, in particular approx. 60%, in the form of a substantially equal mixture of gelatin, pectin and Na-carboxymethyl cellulose.

30

The ratio of the amount of polyisobutylene to butyl rubber in the first material unit depends on how cohesive and thus how fluid retardant it is desired for the material to be. The higher the content of butyl rubber, the more cohesive the material becomes. Furthermore, the less cohesive material which constitutes one or more other units may also contain a smaller amount of butyl rubber.

Alternatively, the cohesive first material unit may consist of an adhesive material such as that disclosed in DK Patent No. 147,034 (similar to US Patent No. 4,231,369) and described previously.

A skin peel product according to the invention can e.g. consisting of a first cohesive adhesive material unit and one or more 10 other material units of a less cohesive adhesive material, the adhesive materials have the following compositions indicated in% by weight: 15 20 25 30 35 DK 169711 B1 - 10 -

Less cohesive Cohesive adhesive adhesive 5 Polyisobutylene (PIB) 40-60

Styrene Isoprene Styrene (SIS) 5-20

Oil 5-30

Resin 10-30

Na-carboxymethyl cellulose (CMC) 25-40 25-40 10 Guar 10-25 10-25 PIB can e.g. be the aforementioned "Vistanex LM-MH".

15 SIS can e.g. be the "Cariflex TR 1107" sold by SHELL.

The oil can e.g. be a paraffin oil.

The resin may e.g. be a fully hydrogenated synthetic thermoplastic resin such as "Arkon 90" sold by Arakakawa (Japan).

The cohesion of an adhesive can be measured empirically, e.g. by measuring how quickly or to what extent the material disintegrates upon contact with excess liquid. The faster or the higher the degree of disintegration, the less cohesive the material.

With a skin plate product of this preferred embodiment, i. with a first very cohesive self-adhesive material unit and at least one other less cohesive self-adhesive material unit, the following advantageous use properties are obtained simultaneously: 35 - 11 - DK 169711 B1

Rapid initial aspiration of fluid from the skin surface is achieved, resulting in an improved initial adhesiveness. The less cohesive adhesive will very quickly lead the liquid away from the skin and into the skin plate product.

Good persistent adhesion is achieved, since the less cohesive adhesive layer is similarly plastic and will mold to follow the uneven shape of the skin surface.

10

A long-life skin plate product is obtained, with the liquid slowly but constantly being passed from the less cohesive adhesive to the more cohesive material, so that the leaching of the less cohesive adhesive material is substantially reduced compared to the leaching of skin plate products consisting of it. less cohesive adhesive material alone.

A skin plate product is obtained which leaves less adhesive residue upon removal than skin plate products, where the adhesive material alone is of a less cohesive adhesive material. This is also related to the reduced leaching of the less cohesive adhesive.

A skin plate product can be obtained which, when compared to skin plate products without liquid barrier layers, has a reduced tendency to undesirably absorb fluid from the edges, e.g. water during bathing, or ostomy secretion in cases where it is used to hold ostomy equipment.

30

A wide variety of other materials may be included in the product of the invention, either as standalone units or as parts of adhesive-containing units. By way of example, one or more species of material units may consist of a foam material with open or closed cells. In the foam material there may be a biologically active substance present in DK 169711 B1 - 12, e.g. a drug or antiseptic or antibiotic. The biologically active substance may be in the cells of an open cell foam or be present in the foam material itself, ie in the walls of open or closed cells, e.g. may consist of a foamed gel material such as gelatin.

Biologically active substances may also be present in materials other than foams. For example. For example, one or 10 more material units may be made up of a hydrophilic gel material which includes a wart treatment agent, e.g. cantharidine, salicylic acid, silver nitrate, podophylline or an antimetabolic cytostatic such as cytarabine, fluorouracil or mercaptopurine.

15

One or more material units may be made up of a hydrophilic gel material comprising one or more keratolytically active substances, e.g. carbamide, salicylic acid and / or lactic acid.

20

Furthermore, one or more material units may contain one or more mitosis-inhibiting compounds, e.g. anthracene, silver nitrate or glucocorticoids such as weak, medium or strong acting coticosteroids such as hydrocortisone, triamcinoline acetonide or betamethasone.

As mentioned earlier, one or more of the material units may be gels with adhesive properties, or they may be gels without adhesive properties. Such gel materials may be hydrophilic or hydrophobic, optionally with desired HL (hydrophilic-lipophilic balance) balance, and optionally a support structure therein may be included in the form of a foam of e.g. polyether, collagen or gelatin, or in the form of fibers, filaments or woven or nonwoven textile material, e.g. of polyester or cotton. Hydrophilic gels can e.g. be mixtures of karaya and glycerol; of pectin, relatively low molecular weight polyethylene glycol and glycerol; or mixtures of gelatin, glycerol and water.

Hydrophobic gels can e.g. consist of mixtures of styrene-5-isoprene-styrene block copolymer and paraffin oil; mixtures of styrene-isoprene-styrene block copolymer, paraffin oil and dioctyl adipate; or mixtures of nitrocellulose, castor oil and rosin.

10 As examples of active substances which may be included in the gel materials may also be mentioned antiseptics such as iodophores, silver compounds, hexidine or chlorhexamine, vitamins and antibiotics, wound healing agents and growth promoters such as growth hormone.

15

Foam materials which may form part of a particular kind of material unit or form a support structure in the gel materials just described can e.g. be polyether, polyethylene, polyvinyl chloride, polyurethanes, gelatin or collagen.

20

Furthermore, one or more of the material units may consist of or contain alginate, e.g. in the form of an anginate mat, preferably containing a mixture of sodium and calcium alginate. Mention of such alginate materials may e.g. can be found in EP Patent Application No. 243,069.

The skin plate product may also include one or more material units with so-called superabsorbent materials. Such materials are well known in connection with 30 absorbent products such as sanitary napkins and diapers.

Further, the skin plate product of the invention may include one or more material units of hydrophilic electrically conductive gel material, optionally surrounded by aluminum foil e.g. consisting of a base polymer such as polyacrylamide, salts of polymetacrylic and polyacrylic acids, polyvinyl alcohol or Na-CMC, softened with a low-cost plasticizer, e.g. a liquid polyol such as glycerol and optionally with the addition of typically 0.1-1.5%

NaCl, KCl or other biologically harmless, easily soluble salt and optionally 1-10% water.

As mentioned, the skin plate product according to the invention consists of at least two material units of different material, the first material unit constituting at least part of the first surface and the second surface respectively, the first material unit possibly constituting the entire one surface.

The other surface area is constituted by the other material unit (s), which extends at least a distance into the thickness of the product in a direction which cuts the said surface and is preferably perpendicular thereto, but may also have a slightly oblique angle. The other material units preferably have a thickness of between 0.1 and 3 mm, especially between 0.5 and 1.5 mm, preferably having a thickness of less than 3/4 of the total thickness of the product and more preferably of less than 1/2 of the total thickness of the product.

25 If both surfaces have areas made up of Other material units that overlap, it is necessary that these material units together have a thickness not exceeding the thickness of the total product.

30

The surface areas or area constituted by one or more other material units may each have a surface extension of the shape of an island, preferably with a minimum width of more than 0.5 mm.

35 - 15 - DK 169711 B1

If there is only one island, it can suitably have a minimum width of between 25 and 50 mm.

By 0 is meant a substantially circular, oval, square, or rectangular surface.

The surface area (s) constituted by other material units may also be one or more concentric circular or circumferential web areas, preferably having a web width of between 0.5 mm and 10 mm, and more preferably between 1 and 5 mm.

If there are two or more concentric web areas of other material units, the first material unit 15 preferably constitutes a circular or circumferential surface area between the concentric web areas of the other material units having a width of between 1 and 20 mm, and more preferably between 1 and 5 mm. the web areas of the first material unit being preferably 0.3-3 times wider than the web areas of other material units.

Of course, the surface areas made up of the other material units can have many other designs. For example, they can have the shape of one or more stripes, arches, triangles, spirals or combinations thereof, and of the designs described above. However, for the purpose of manufacturing the product, it is desirable that these surface areas have a minimum width of more than 0.5 mm.

The product according to the invention may be chicurl, oval, square or rectangular or any other design. For use in ostomy equipment, the product of the invention can e.g. have a central hole.

The configuration of the material units as well as the choice of materials is, of course, dependent on the use intended for the skin plate product according to the invention, ie. what properties you want the product to have, as well as the total area and thickness of the product depends on this.

5

However, it is preferred that the product according to the invention has a total thickness of less than 4 mm and preferably less than 2 mm.

Furthermore, it is generally preferred that the first material unit be a skin-friendly adhesive and that at least one of two contact material units is self-adhesive.

The invention also relates to a method for producing the skin plate product according to the invention, which is characterized by the characterizing part of claim 17.

The flat plate produced in step 1 is prepared in a generally known manner by coating, extrusion or pressing.

The flat plate produced may optionally be cut into 25 pieces having substantially the desired product periphery. However, it is preferable to wait with the cutout until the other material units are incorporated into the plate.

If both surfaces of the product are to have arals constituted by other material units, it is advisable to perform this in two steps, first pressing the material units into one surface and then into the other. Alternatively, it can be performed in 1 step by simultaneously pressing other material units into both surfaces.

35 - 17 - DK 169711 B1

If only one surface of the product is to have areas made up of other material units, the other surface may, if desired, be coated with a film material or the like.

5

The other material units can e.g. manufactured by extrusion or cutting / punching of sheets or laminates, such as may include mesh or foil. A further material unit can further be produced by the method of preparation according to the invention.

If the other units are to be pressed into the flat plate, it is important that the other units are harder than the flat plate at the moment of pressing. This can be regulated by pre-cooling the other material unit (s) and / or heating the first material unit.

20 The optimum impression speed depends on the nature of the materials and especially on their plastic / elastic properties.

If you first depress depressions in the flat plate 25 and then place the other material units in the recesses, it may still be desirable to exert a slight pressure on the other material units to ensure that they are securely placed.

Furthermore, immediately before or during the final punching of the product according to the invention, it may be convenient to give the product a slight heating and / or run it through calibration rollers to ensure that the material units are sufficiently connected and have 35 flat faces.

- 18 - DK 169711 B1 In the following and with reference to the drawings, the invention is further described.

FIG. 1 shows a first embodiment of the skin plate product according to the invention from the side facing a skin surface; FIG. 1 'shows a variation of the one shown in FIG. 1, FIG. 1a-1c show a section along the line-I 'of variations of the skin plate product shown in FIG. 1, FIG. 2 shows another embodiment of the skin plate product 15 according to the invention seen from the intended side of a skin surface; FIG. Figure 3 shows a third embodiment of the skin plate product according to the invention; 3a shows a section along line III'-III 'of the skin plate product shown in FIG. 3, FIG. 4 shows a fourth embodiment of the skin plate product according to the invention seen from the side facing a skin surface; FIG. 4a shows a section in line IV-IV of the skin plate product shown in FIG. 4, 30 FIG. 5 shows a fifth embodiment of the skin plate product according to the invention seen from the intended side facing a skin surface; FIG. 5a shows a section in line V-V of the skin plate product shown in FIG. 5th

DK 169711 B1 - 19 -

The FIG. 1, the skin plate product consists of a first material unit 1 and three other material units 2. The skin plate product has a first surface not shown and a second surface intended to face a skin surface.

5

The second surface is constituted by the first material unit 1 and concentric web areas of the other three material units 2 which are pressed into the first material unit 1.

In the figure shown, three other circular web areas of other material units are drawn, but there may as well be 1, 2, 4 or more web areas, and they may also have any other circular configuration.

15 The skin plate product shown is particularly suitable for use in ostomy equipment, and therefore the product has a central hole 3.

However, the product may as well be constructed without this hole, e.g. for use in a wound dressing.

20

The first material unit 1 is preferably of a liquid-absorbent skin-friendly adhesive material with a high cohesion, as previously described, and the other material units are preferably of a liquid-absorbent, skin-friendly adhesive material with a lower cohesion, as previously described.

A skin plate product having such a construction and with such a material composition is particularly suitable for use as a semi-finished product in ostomy equipment or wound dressings, especially for liquid wounds, thereby achieving a control of the fluid migration in the skin plate product and thus a rapid initial fluid absorption and good and long-term adhesiveness, as previously described.

35 - 20 - DK 169711 B1

FIG. 1a shows a section along line 1-1 'of the one in FIG. 1. It can be seen that the first material unit 1 extends throughout the area of the product and constitutes the whole of the first surface 6 and partly the second surface 5, while 5 the other parts of the second surface 5 are constituted by Other material units 2 which extend for a while. the first material unit 1, the three other material units extending to the same depth and forming an angle with the surface 5 which is substantially perpendicular.

10

FIG. 1b and 1c are sections in the line 1-1 'of variations of that of FIG. 1, wherein reference numerals 1, 5 and 6 show similar parts as described in FIG. la.

In FIG. Ib are the three other material units 2 of different materials, e.g. with variations in cohesion and possibly absorbent ability, and they extend to different depths.

In FIG. 1c, the three other material units form angles to the surface so that they decrease in width from the surface 5 into the skin plate product, and furthermore, the skin plate product comprises a fourth remaining unit which constitutes a surface area of the first surface 6, e.g. in the form of a circular-25 course area.

This fourth other unit may e.g. be of a very adhesive and not necessarily skin-friendly adhesive. The unit is intended to be glued to e.g. an ostomy device or a back cover layer.

The FIG. 1 'skin plate product is a variation of that of FIG. 1, consisting of a first material unit 1 'and 28 other material units 2', 35, and having a first surface not shown and a second surface intended to face a skin surface.

DK 169711 B1 - 21 -

The second surface is constituted by the first material unit 1 'and by the other material units 21 which are pressed into the first material unit, so that they constitute 7 broken web areas of the surface.

5

The number of course areas may, of course, be different.

Furthermore, the skin plate product may have a central hole not shown.

10

The preferred material composition of materials 1 'and 2' is as for the corresponding units 1 and 2 of FIG. First

The depression depth of the other material units may vary in the same manner as shown in FIG. la-lc.

The FIG. 2, the skin plate product broadly similar to that of FIG. 1, consisting of a first material unit 11 and a second material unit 12 and 20 having a first surface not shown and a second surface constituted by the two material units, the remaining material unit 12 constituting a helical area.

The FIG. 2 has three turns but may, of course, have more or less if desired.

The skin plate product has a central hole, being intended for use in ostomy equipment.

A similar skin plate product without a hole can e.g. used as a semi-finished product for a wound dressing.

The preferred material compositions are as indicated in the description of FIG. First

35 - 22 - DK 169711 B1

The FIG. 3 and 3a show a skin plate product having a first and a second surface 26, 25, consisting of a first material unit 21 and a number of other material units 22 constituting a surface area of the second surface 25 in the form of 5 circular islands.

In principle, there may be more or fewer islands than shown, and they may be square, oval, or any other shape.

10

In FIG. 3a, it appears that the other units extend to a depth in the first unit which is the same for all other units and having an angle substantially perpendicular to the second surface. "It must be understood that 15 these units as well may have a different angle to the surface, as well as being able to extend to different depths.

The first material unit is preferably made of a skin-friendly self-adhesive material, optionally containing hydrocolloid.

If the skin plate product is to be used as a semi-finished product for a wound or skin care dressing, and the first surface is intended to face the skin surface, the other units may e.g. contain one or more medications as previously described and optionally be adhesive and / or liquid absorbent.

30 If the skin plate product shown in FIG. 3 is to be used as a semi-finished product in an ostomy device or as a holding device for wound drains or catheters, it preferably has a material composition as described in FIG. First

35 The embodiment of FIG. 4 and 4a, the skin plate product shown is particularly suitable as a semi-finished product in a wound or skin plate product and has a first surface 36 to which a back cover layer or the like and a second surface 35 can be attached to face a skin surface.

The product consists of a first material unit 31 of a skin-friendly self-adhesive liquid-absorbent relatively highly cohesive material and a second material unit 32 of a skin-friendly self-adhesive liquid-absorbent less cohesive material which, with the exception of the upper surface, surrounds a third material unit 33 of a material containing a biological material. active component. This material can e.g. be of the type disclosed in Danish Patent No. 154,806, which consists of a continuous water-insoluble phase and a discontinuous phase dispersed therein, which is water-soluble or water-swellable, and wherein the drug is incorporated in the discontinuous phase. Thus, the incorporated drug will be released as fluid dissolves or swells in the discontinuous phase.

The surrounding material unit 32 provides excellent adhesive properties to the dressing, and the first material unit 31 prevents or reduces fluid seepage from e.g. the catheters as well as reducing the fluid dissipation from the third material unit 33, which results in almost complete utilization of active substance in the third material unit.

Alternatively, the skin plate product may be constructed without the second material unit, the third material unit being designed and assembled according to the size of the wound and the exudate amount so as to obtain a sufficient adhesive capacity.

Alternatively, the third material unit may be made of an open cell foam material containing a drug or a non-drug foam material.

35 - 24 - DK 169711 B1 In a particularly preferred embodiment, the third material unit is an alginate material, e.g. an alginate mat and optionally without the presence of the second material unit.

5

As a further alternative, the second material unit constituting a circumferential surface path of the surface may be configured so as not to cover the inner surface 33 'of the third material unit.

10

The FIG. 5 and 5a is also particularly suitable for use as a semi-finished product for wound or skin care products and has a first surface 46 and a second surface 45.

It consists of a first material unit 41, a number of material units 42 and a material unit 43.

The first surface 46 is constituted by the first material unit 41, and the second surface 45 is partially formed by the first material unit 41, a centrally located circular island, which may as well have been square or had a different extent, of the third material unit and a the number of surface webs arranged as a discontinuous circular web constitutes the other parts of the second surface.

25

The interrupted circular path of the units 42 can, of course, be configured as a non-interrupted path and have any other circumferential extent.

Alternatively, the material units 42 may be omitted.

It can be seen from FIG. 5a, that the material unit 43 forms an angle with the surface 45 so that it increases in width from the surface 45 and into the material unit 41. In order to achieve this configuration, it is necessary that the material unit 43 is of a easily deformable material, e.g. . a foam material.

DK 169711 B1 - 25 -

By placing as shown, a better holding of the material unit 43 is obtained.

The preferred materials for the respective units 41, 42 5 and 43 are respectively for the units 31, 32 and 33 of FIG.

1.

10 15 20 25 30 35

Claims (16)

1. Adhesive, flat skin plate product for use as a semi-product in the manufacture of electrodes, dressings, skin and wound care agents, dressing retaining organs, ostomy equipment, wound sinks and catheters for incontinence equipment, especially for men, and for use in skin electrodes, which skin plate product has an area extension defined by the periphery of the product 10 and a first surface and a second surface and consisting of two or more substantially unmixed material units (1, 1 ', 2, 2', 2a, 2b, 2c, 4, 11, 12, 21, 22, 31, 32, 33, 41, 42, 43), wherein at least two material units are of different material, of which at least one material unit is a skin-friendly self-adhesive material, characterized in that a first material unit (1 1, 11, 21, 31, 41) extend throughout the entire area of the product, this material unit further comprising at least part of the first surface (6, 26, 36, 46) and the second surface (5, respectively). 25, 35, 45), and where the other (s) material units constitute the remaining portion of the first and second surfaces, respectively, and have a thickness extending at least one portion into the thickness of the product in a direction that cuts the first or second surface of the product. Skin plate product according to claim 1, characterized in that the first material unit (1, 11, 21, 31, 41) constitutes the entire first surface (6, 26, 36, 46). 30 Skin plate product according to any one of claims 1 and 2, characterized in that the other material units (2, 2 ', 2a, 2b, 2c, 12, 22, 32, 33, 42, 43.) have a thickness of less than 3/4, and preferably 35 less than 1/2, of the total thickness of the product, the thickness of the other material unit (s) being preferably between 0.1 and 3 mm, and more preferably between 0, 5 and 1.5 mm. Skin plate product according to any one of claims 1-3, characterized in that there are two or more other material units (2, 2 ', 2a, 2b, 2c, 22, 32, 33, 42, 43), and that they may have different thicknesses. Skin plate product according to any one of claims 1-4, characterized in that at least one Other material unit (2, 2a, 2b, 2c, 32) constitutes a circular or circumferential surface web of the first or second surface, and in particular that two or more other material units (2, 2a, 2b, 2c) form circular or circumferential surface webs of the first or second surface and that these surface webs are substantially concentrically disposed. Skin plate product according to claims 1-4, characterized in that several other material units (2 *, 42) together form at least one circular or circumferential discontinuous web area, these web areas, if there are several, arranged concentrically. Skin plate product according to claim 5 or 6, characterized in that a circular or circumferential surface area of surfaces between two consecutive concentric, possibly interrupted, surface webs of other material units (2, 2 ', 2a, 2b, 2c) is constituted by the first material area (1, 1 '), and that these area ranges are between 0.3 and 3 times as wide as the narrowest of the area webs 30 of other material units. Skin plate product according to any one of claims 1-4, characterized in that at least one other material unit (22, 33, 43) constitutes an island-shaped, preferably 35 circular or square area of the first or second surface (25). , 26, 35, 36, 45, 46). DK 169711 B1 - 28 - Skin plate product according to claim 8, characterized in that it has a centrally located island-shaped area of another material unit (33, 43) and optionally further has on the same surface one or more surface webs of 5 other material units (32, 42) constituting one or more circumferential or non-interrupted circular or circumferential acreage areas around the island-shaped area. Skin plate product according to any one of claims 10 to 9, characterized in that the first material unit (1, 1 ', 11, 21, 31, 41) is of a self-adhesive skin-friendly material. Skin plate product according to any one of claims 1 to 10, characterized in that at least one of the material units (1, 1 ', 2, 2', 2a, 2b, 2c, 4, 11, 12, 21, 22, 31, 32, 33, 41, 42, 43) consists of a material that inhibits or prevents the migration of substances to and from contact with these material units self-adhesive material units. Skin plate product according to claim 1, characterized in that at least one of the material units consists of a hydrocolloid-containing material which inhibits or prevents the passage of aqueous liquids to the hydrocolloid-containing self-adhesive material units in contact with these material units. Skin plate product according to claim 12, characterized in that the first material unit is of a skin-friendly liquid-absorbing adhesive material with a high relative cohesion and that at least one other material unit (2, 2 ', 2a, 2b, 2c, 12, 22 , 32, 42) is of a skin-friendly liquid-absorbing adhesive material with a lower cohesion. - 29 - DK 169711 B1 Skin plate product according to any one of claims 1-13, characterized in that at least one of the material units (1, 1 ', 2, 2', 2a, 2b, 2c, 4, 11, 12, 21, 22, 31 , 32, 33, 41, 42, 43) contain one or more 5 biologically active substances. Skin plate product according to claim 14, characterized in that at least one material unit (1, 1 ', 2, 2', 2a, 2b, 2c, 4, 11, 12, 21, 22, 31, 32, 33, 41, 42 , 43) is made up of a hydrophilic gel material comprising an anti-warts agent or containing one or more mitosis-inhibiting compounds. Skin plate product according to claim 14, characterized in that at least one material unit (33, 43) is an alginate material. A method of producing a skin plate product according to claims 1-16, characterized in that 20 i) of the material which is to constitute the first material unit produces a flat plate having a thickness substantially equal to the thickness of the desired product. and optionally cutting this into smaller pieces having a periphery corresponding to the desired product periphery; (ii) manufactures the other material unit (s) of substantially the widths and thicknesses which they must have in the finished product; (iii) depresses the other material unit (s) into the first material unit, before cooling, if necessary, the other material unit (s) and / or heating the first unit of material so that the other material unit (s) is harder than the first unit of material at the moment of impression; or depresses indentations in the plate corresponding to the width, thickness and desired configuration of the other material unit (s), after which the other material unit (s) is placed in the recesses; and iv) punching or cutting the product to the desired periphery if not done in step i). 15 20 25 35